Condition category
Digestive System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
19/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Will Bernal

ORCID ID

Contact details

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 020 7737 4000xt 4458
william.bernal@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0116169596

Study information

Scientific title

Acronym

Study hypothesis

One of the most severe complications of acute liver failure (ALF) is the development of brain swelling know as cerebral oedema (CO). This may rapidly lead to the development of raised pressure within the skull cavity and fatal brain injury may occur. A key part of the care of patients with ALF is therapy to reduce the likelihood of CD developing.
One of these forms of therapy is to cool the patient, inducing a controlled level of hypothermia. Human studies have suggested that this may be very effective in treating established CO and indeed we are already using it in this way. However, it is not known whether mild hypothermia is also effective in preventing the complication from developing in the first place.
We already cool all ALF patients to around 36 degrees centigrade, but there is evidence from studies in both animals and humans that further reductions in temperature are of even greater benefit. We now wish to perform a randomised controlled clinical trial to establish what temperature is of greatest benefit to patients in preventing the development of CO.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Digestive System: Acute liver failure (ALF)

Intervention

Randomised controlled trial

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Onset of ICH, development of a sustained rise of ICP (>5 minutes of ICP > 25 mmHb)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2005

Overall trial end date

01/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2005

Recruitment end date

01/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Kings College Hospital NHS Trust R&D Consortium

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own Account

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes